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A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02130557
Recruitment Status : Active, not recruiting
First Posted : May 5, 2014
Results First Posted : November 14, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Condition or disease Intervention/treatment Phase
Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive Drug: Bosutinib Drug: Imatinib Phase 3

Detailed Description:
The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 536 participants
Allocation: Randomized
Masking: None (Open Label)
Masking Description: NOTE: Value was Open Label in old format; This study has an open-label design. Although most efficacy studies have a double blind design, this is not feasible in this trial, due to the complexity of the dose reduction and dose escalation schemes with tablets of various sizes, dosage strengths, as well as the number of tablets that would be required daily. However, the opportunity for bias is mitigated by the use of objective outcome measures (MMR, CCyR, CHR). The Investigators will be instructed to ensure that laboratory/pathology personnel are blinded to treatment information. For these reasons, an open-label, randomized study is appropriate.
Primary Purpose: Treatment
Official Title: A Multicenter Phase 3 Randomized, Open-label Study Of Bosutinib Versus Imatinib In Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Actual Study Start Date : July 22, 2014
Actual Primary Completion Date : August 11, 2016
Estimated Study Completion Date : April 4, 2020


Arm Intervention/treatment
Experimental: Bosutinib
Bosutinib, 400 mg, oral administration once a day
Drug: Bosutinib
Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia positive (Ph+) chronic phase (CP), accelerated phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML) previously treated with other TKI inhibitor therapy.[1] This study will investigate the use of bosutinib as first-line treatment for patients with Ph+ CP CML.

Active Comparator: Imatinib
Imatinib, 400 mg, oral administration once a day
Drug: Imatinib

Imatinib mesylate (referred to in this protocol as imatinib) is an inhibitor of the BCR-ABL kinase and been the standard first-line therapy for patients with chronic-phase CML. Imatinib was granted approval by the European Commission in November 2001 and by the FDA in December 2002 for the treatment of newly diagnosed patients with CP Ph+ CML based on results from the IRIS trial.

Imatinib is considered the standard of care for both first-line and later line settings, and consequently is an appropriate active comparator.





Primary Outcome Measures :
  1. Percentage of Participants With Major Molecular Response (MMR) at Month 12 [ Time Frame: Month 12 ]
    MMR was defined as a ratio of breakpoint cluster region to abelson (Bcr-Abl/Abl) less than or equal to (<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to [>=] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts [>=3000 Abl required]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR).


Secondary Outcome Measures :
  1. Major Molecular Response (MMR) by Month 18 [ Time Frame: up to Month 18 ]

    MMR was defined as a ratio of Bcr-Abl/Abl <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts [>=3000 Abl required]) by quantitative RT-qPCR.

    It will be tested at the 1-sided significance level of 0.0125.


  2. Duration of Major Molecular Response (MMR) [ Time Frame: From the date of first MMR until the date of confirmed loss of MMR or censoring (up to 752 days) ]
    It was defined as the time from the first date of MMR until the date of the confirmed loss of MMR or censoring. Confirmed Loss of MMR was Bcr-Abl/Abl IS ratio >0.1% in association with a >=5-fold increase in Bcr-Abl/Abl IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase or blast phase CML. Kaplan-meier analysis was used for determation of duration of MMR. Duration of response will be analyzed for responders only therefore duration of response will be excluded from the long-term family of secondary outcome measures.

  3. Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12 [ Time Frame: up to Month 12 ]
    Complete Cytogenetic Response (CCyR) was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 % Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available.

  4. Duration of Complete Cytogenetic Response (CCyR) [ Time Frame: From the date of first CCyR until the date of confirmed loss of CCyR or censoring (up to 752 days) ]
    It was defined as the time from the first date of CCyR until the date of the confirmed loss of CCyR or censoring. Confirmed Loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to accelerated phase or blast phase CML. Kaplan meier analysis was used for the determination of duration of CCyR. Duration of response will be analyzed for responders only therefore duration of response will be excluded from the long-term family of secondary outcome measures.

  5. Cumulative Incidence of Event Free Survival (EFS) Events at Month 12 [ Time Frame: Month 12 ]
    EFS was defined as the time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR [chronic phase, AP, or BP] confirmed by 2 assessments at least 4 weeks apart). Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of <100 metaphases confirmed by a follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS event at month 12 was adjusted for competing risk of treatment discontinuation without the event. The comparative analysis between the two arms for this member of the long-term secondary family will be done at the end of the study.

  6. Percentage of Participants Alive at Month 12 [ Time Frame: Month 12 ]
    OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. The comparative analysis between the two arms for this member of the long-term secondary family will be done at the end of the study. Percentage of participants who were alive were estimated in this outcome measure.


Other Outcome Measures:
  1. Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) [ Time Frame: Day 28, 56, 84 ]
    CCyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0 % Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure.

  2. Summary of Trough Plasma Concentration by Major Molecular Response (MMR) [ Time Frame: Day 28, 56, 84 ]
    MMR was defined as a ratio of Bcr-Abl/Abl <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) by quantitative RT-qPCR. Trough plasma concentration of participants who had MMR are presented in this outcome measure.

  3. Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) [ Time Frame: Day 28, 56, 84 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.

  4. Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs) [ Time Frame: Day 28, 56, 84 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. Trough plasma concentration of participants who had grade 3 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separatley for each preferred term of AE.

  5. Number of Participants With Vital Signs Abnormalities [ Time Frame: Baseline up to 752 days ]
    Criteria for vital signs abnormalities: systolic blood pressure (SBP) <80 millimeter of mercury (mmHg), >210 mmHg; diastolic blood pressure (DBP) <40 mmHg, >130 mmHg; heart rate <40 beats per minute (bpm), >150 bpm; temperature <32 degree celsius, >40 degree celsius.

  6. Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03 [ Time Frame: Baseline up to 752 days ]
    Laboratory parameters included hematological (haemoglobin, lymphocytes (absolute), neutrophils (absolute), platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.

  7. Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern [ Time Frame: Baseline up to 752 days ]
    Criteria for ECG abnormalities : heart rate: increase of >15 bpm from baseline value and >=120 bpm, decrease of >15 bpm from baseline value and <=45 bpm; PR interval: change of >=20 msec from baseline value and >=220 milliseconds (msec); QRS interval >=120 msec; QTcB interval >500 msec, increase of >60 msec from baseline; QT interval using Fridericia's correction (QTcF) >500 msec, increase of >60 msec from baseline, <=450 msec (Men) or <=470 msec (Women), >450 msec (Men) or >470 msec (Women).

  8. Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation [ Time Frame: Baseline up to 752 days ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  9. Number of Participants With Treatment-Emergent Adverse Events By National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) [ Time Frame: Baseline up to 752 days ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.03. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 752 days that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).
  2. Adequate hepatic, renal and pancreatic function.
  3. Age ≥ 18 years.

Exclusion Criteria:

  1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region.
  2. Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.
  3. Extramedullary disease only.
  4. Major surgery or radiotherapy within 14 days of randomization.
  5. History of clinically significant or uncontrolled cardiac disease.
  6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, cirrhosis or evidence of decompensated liver disease. Patients with resolved Hepatitis B can be included.
  7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
  8. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
  9. Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130557


  Hide Study Locations
Locations
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Investigational Drug Service, Emory University Clinic
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States, 96819
United States, Idaho
Saint Alphonsus Regional Medical Center, Cancer Care Center
Boise, Idaho, United States, 83706
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Saint Alphonsus Caldwell Cancer Care Center
Caldwell, Idaho, United States, 83605
Saint Alphonsus Medical Center Nampa
Nampa, Idaho, United States, 83686
United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D
Indianapolis, Indiana, United States, 46237
United States, Louisiana
Cancer Center of Acadiana at Lafayette General Medical Center
Lafayette, Louisiana, United States, 70503
Lafayette General Medical Center
Lafayette, Louisiana, United States, 70503
Drug shipment address: University Health Shreveport
Shreveport, Louisiana, United States, 71103
LSU Health Sciences Center-Shreveport
Shreveport, Louisiana, United States, 71103
University Health Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Center for Cancer and Blood Disorders
Germantown, Maryland, United States, 20874
United States, Massachusetts
Drug Shipment: University of Massachusetts Memorial Medical Center, Oncology Research Pharmacy
Worcester, Massachusetts, United States, 01655
Univertsity of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
St. Joseph Mercy Hospital - Inpatient Pharmacy
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy-Brighton
Brighton, Michigan, United States, 48114
St. Joseph Mercy-Canton
Canton, Michigan, United States, 48188
Chelsea Community Hospital
Chelsea, Michigan, United States, 48118-1370
St. John Hospital&Medical Center
Detroit, Michigan, United States, 48236
St. John Hospital&Medical Center-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, United States, 48236
Van Elslander Cancer Center, Pharmacy
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
Minnesota Oncology Hematology, PA
Edina, Minnesota, United States, 55435
Park Nicollet Frauenshuh Cancer center
Saint Louis Park, Minnesota, United States, 55426
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
United States, Mississippi
North Mississippi Hematology and Oncology Assoc., Ltd
Tupelo, Mississippi, United States, 38801
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
NYU Winthrop University Hospital
Mineola, New York, United States, 11501
Winthrop University Hospital - Pharmacy Department
Mineola, New York, United States, 11501
Beth Israel Medical Center
New York, New York, United States, 10003
University of Rochester Investigational Drug Pharmacy
Rochester, New York, United States, 14642
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States, 28374
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
UC Health Physicians Office South,
West Chester, Ohio, United States, 45069
United States, South Carolina
MUSC University Hospital
Charleston, South Carolina, United States, 29425
MUSC University of South Carolina, Investigational Drug Services
Charleston, South Carolina, United States, 29425
MUSC-Hollings Cancer Center
Charleston, South Carolina, United States, 29425
GHS Cancer Institute
Easley, South Carolina, United States, 29640
GHS Cancer Institute
Greenville, South Carolina, United States, 29605
GHS Cancer Institute
Greenville, South Carolina, United States, 29615
GHS Cancer Institute
Greer, South Carolina, United States, 29651
GHS Cancer Institute
Seneca, South Carolina, United States, 29672
GHS Cancer Institute
Spartanburg, South Carolina, United States, 29307
United States, Texas
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists
American Fork, Utah, United States, 84003
Utah Cancer Specialists
Bountiful, Utah, United States, 84010
Utah Cancer Specialists
Layton, Utah, United States, 84041
Utah Cancer Specialists
Murray, Utah, United States, 84157
Utah Cancer Specialists
Provo, Utah, United States, 84604
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84102
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Utah Cancer Specialists
West Jordan, Utah, United States, 84088
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
Green Bay Oncology, Ltd./HSHS St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
HSHS St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology, Ltd./HSHS St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States, 54303
HSHS St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States, 54303
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
St George Hospital - Hematology Department
Kogarah, New South Wales, Australia, 2217
Australia, Victoria
Eastern Clinical Research Unit, Level 2
Box Hill, Victoria, Australia, 3128
Belgium
UZ Ghent, Hematology Department
Ghent, Belgium, 9000
Department of Haematology at UZ Leuven (7 th Floor)
Leuven, Belgium, 3000
Hematology Department of CHU de Liège
Liège, Belgium, 4000
Hematology Department CHR Verviers
Verviers, Belgium, 4800
Canada, New Brunswick
Horizon Health Network - The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHU de Québec - Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada, G1J 1Z4
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Czechia
Fakultní Nemocnice Brno
Brno, Czechia, 625 00
Fakultní Nemocnice Hradec Králové
Hradec Králové, Czechia, 500 05
Fakultní nemocnice Olomouc
Olomouc, Czechia, 775 20
Všeobecná fakultní Nemocnice v Praze
Prague, Czechia, 128 08
Denmark
Aalborg University Hospital
Aalborg, Denmark, 9000
Aarhus University Hospital
Aarhus, Denmark, 8000
Roskilde Hospital
Roskilde, Denmark, 4000
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029 HUS
France
Oncologie Centre de Radiotherapie
Strasbourg, NC, France, 67000
Institut Bergonié
Bordeaux, France, 33076
private Practice of Pr Philippe Rousselot
Le Chesnay, France, 78157
private Practice of Dr. Viviane Dubruille
Nantes cedex 1, France, 44093
Hôpital L'Archet 1-CHU Nice
Nice, France, 06202
Centre Hospitalier Universitaire de Nîmes
Nimes, France, 30029
INSERM CIC 1402 - CHU Poitiers
Poitiers, France, 86021
Private Practice of Dr. Francoise Huguet
Toulouse cedex 9, France, 31059
Germany
Universitätsklinikum Bonn
Bonn, RP, Germany, 53105
Uniklinikum Aachen
Aachen, Germany, 52074
Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie
Berlin, Germany, 13353
Universitätsklinikum Freiburg, Klinik für Innere Medizin I
Freiburg, Germany, 79106
Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum
Hamburg, Germany, 20251
Universitätsklinikum Jena, Klinik für Innere Medizin II
Jena Lobeda-Ost, Germany, 07747
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, Germany, 39104
Hungary
Semmelweis Egyetem I. Belgyógyászat
Budapest, Hungary, 1083
Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék
Debrecen, Hungary, 4032
Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg
Györ, Hungary, 9023
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary, 7400
Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz.
Szeged, Hungary, 6725
Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet
Szolnok, Hungary, 5004
Israel
Hematology Department, Rambam Medical Centre
Haifa, Israel, 31096
Hematology Div. Davidoff Cancer Center, Rabin Medical Center
Petah-Tikva, Israel, 49100
Italy
USC Ematologia, A. O. Papa Giovanni XXIII
Bergamo, Italy, 24127
Policlinico S. Orsola - Malpighi,
Bologna, Italy, 40138
ASL 8 Cagliari - P.O. Armando Businco
Cagliari, Italy, 09121
Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico
Catania, Italy, 95123
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy, 50134
IRCCS - AOU San Martino_IST, Ematologia 1
Genova, Italy, 16132
Istituto Scientifico San Raffaele
Milano, Italy, 20132
Unità di Ricerca Clinica, U.O. Ematologia Adulti
Monza, Italy, 20900
A.O.U. Policlinico Università degli Studi di Napoli "Federico II"
Napoli, Italy, 80131
Dipartimento di ematologia
Reggio Calabria, Italy, 89124
ASL Roma 2 - Ospedale Sant'Eugenio
Roma, Italy, 00144
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang-si, Korea, Republic of, 14068
Dong A University Hospital
Busan, Korea, Republic of, 49201
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 41931
Chonbuk National University Hospital
Jeonju, Korea, Republic of, 54907
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Seoul St. Mary's Hospital of the Catholic University of Korea
Seoul, Korea, Republic of, 06591
Mexico
Hospital Angeles Pedregal (S.A. de C.V.)
Mexico City, D.f., Mexico, 10700
Monterrey International Research Center
Monterrey, Nuevo LEON, Mexico, 64000
Netherlands
VU University Medical Center
Amsterdam, Noord Holland, Netherlands, 1081 HV
Norway
Haukeland University Hospital Department of Hematology
Bergen, Norway, 5021
St. Olavs Hospital
Trondheim, Norway, 7006
Poland
SPZOZ Zespol Szpitali Miejskich w Chorzowie, Oddział Hematologiczny
Chorzów, Poland, 41500
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, Poland, 80952
Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach
Katowice, Poland, 40032
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii
Kraków, Poland, 31501
UM im. Piastów Śląskich we Wrocławiu Katedra i Klinika Hematologii
Wrocław, Poland, 50-367
Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego
Łódź, Poland, 93510
Singapore
National University Hospital, Main Building
Singapore, Singapore, 119228
Singapore General Hospital
Singapore, Singapore, 169608
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Slovakia
Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda
Bratislava, Slovakia, 851 07
South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa, 2196
Department of Medical Oncology, University of Pretoria and Steve Biko
Pretoria, Gauteng, South Africa, 0002
Mary Potter Oncology Centre
Pretoria, Gauteng, South Africa, 0181
Department of Haematology
Cape Town, Western CAPE, South Africa, 7935
Spain
Hospital (Universitari(o)) Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario La Princesa
Madrid, Málaga, Spain, 28006
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic
Barcelona, Spain, 08036
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Virgen de la Salud
Toledo, Spain, 45004
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Sweden
Linköping University Hospital
Linköping, Sweden, SE-901 85
Skåne University Hospital
Lund, Sweden, SE-221 85
Karolinska University Hospital Solna
Stockholm, Sweden, SE-171 76
Norrlands University Hospital
Umeå, Sweden, SE-901 85
Akademiska Hospital
Uppsala, Sweden, SE-751 85
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, R.o.c., Taiwan, 80708
China Medical University Hospital
Taichung city, R.o.c., Taiwan, 40447
Chi-Mei Medical Center
Tainan City, R.o.c., Taiwan, 710
Thailand
King Chulalongkorn Menorial Hospital
Pathumwan, Bangkok, Thailand, 10330
Phramongkutklao Hospital
Phayatai, Bangkok, Thailand, 10400
Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai University
Muang, Chiang MAI, Thailand, 50200
Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital
Bangkok, Thailand, 10700
Ukraine
MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council
Cherkasy, Ukraine, 18009
Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department
Ivano-Frankivsk, Ukraine, 76008
Khmelnytskyi Regional Hospital, Hematology Department
Khmelnytskyi, Ukraine, 29000
State Institution "National research center for radiation medicine of NAMS of Ukraine",
Kyiv, Ukraine, 03115
transplantation department of hemotology and transplantology division within Clinical Radiology
Kyiv, Ukraine, 03115
Chair of internal medicine #2.
Kyiv, Ukraine, 04112
Kyiv City Clinical Hospital #9, Hematology department #1,
Kyiv, Ukraine, 04112
State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"
Lviv, Ukraine, 79044
United Kingdom
Catherine Lewis Centre, Hammersmith Hospital
London, Greater London, United Kingdom, W12 0HS
Linda McCartney Centre
Liverpool, Merseyside, United Kingdom, L7 8XP
Department of Clinical Haematology
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Cancer & Haematology Centre, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Department of Haematology The Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Heartlands Hospital
Birmingham, WEST Midlands, United Kingdom, B9 5SS
St James's Institute of Oncology
Leeds, WEST Yorkshire, United Kingdom, LS9 7TF
Department of Haematology
Cardiff, United Kingdom, CF14 4XW
The Hope Clinical Trials Unit
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02130557     History of Changes
Other Study ID Numbers: AV001
2013-005101-31 ( EudraCT Number )
B1871053 ( Other Identifier: Alias Study Number )
First Posted: May 5, 2014    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: December 10, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Bosutinib
Leukemia
Myelogenous
Chronic
BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Pathologic Processes
Imatinib
Therapeutic Uses
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors